Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Clobazam (0.25, 0.5 and 1.0 mg/kg/day) in Patients with Lennox-Gastaut Syndrome.

undbeck Inc0 个研究点目标入组 240 人开始时间: 2008年1月21日最近更新: 2012年3月19日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方
入组人数: 240

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•1. The patient or patient?s legally authorized representative (LAR) must sign and date the
•Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved
•Informed Consent Form (ICF)/Health Insurance Portability and Accountability Act
•(HIPAA) Authorization (if required) prior to study participation. If appropriate, the
•patient will sign an Assent Form.
•2. Male or female patients between 2 and 60 years of age (inclusive).
•3. Patient must have been <11 years of age at the onset of LGS.
•4. Patient must weigh ≥12.5 kg.
•5. If female:
•a. Patient is either not of childbearing potential, defined as premenarchal,
•postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation,
•bilateral oophorectomy or hysterectomy), or if of childbearing potential, must
•comply with a method of birth control acceptable to the investigator during the
•study, for at least 30 days prior to randomization and for 30 days following
•completion of the study.
•b. Patient is not breastfeeding.
•c. Patients of childbearing potential must have a negative serum pregnancy test at
•screening and a negative urine pregnancy test performed on Study Day -1.
•6. Patients with LGS as evidenced by:
•a. Greater than 1 type of generalized seizures, including drop seizures (atonic, tonic or
•myoclonic) for at least 6 months.
•b. Written documentation of having met the electroencephalogram (EEG) diagnostic
•criteria for a diagnosis of LGS at some point in their history (must have abnormal
•background activity accompanied by slow spike and wave pattern <2.5 Hz).
•7. Patient must have experienced ≥2 drop seizures per week during the 4-week baseline
•8. Patient must be on at least 1 AED. Patient must be on a stable AED dosing regimen for
•at least 30 days prior to screening. Neither a Vagal Nerve Stimulator (VNS) nor the
•ketogenic diet will count as an AED.
•9. Patients must not have been on any benzodiazepines chronically (for any indication) for
•a period of at least 30 days prior to screening. Patients will be allowed to enter the study
•if they have used benzodiazepines as a rescue therapy within the 30 days prior to
•screening with a limit of 1 rescue per day up to an average of once per week.
•10. In the investigator?s opinion, parent or caregiver must be able to keep an accurate
•seizure diary.
•11. In the investigator?s and parent/caregiver?s opinions, the patient is able to take study
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

排除标准

•1. Etiology of patient?s seizures is a progressive neurologic disease. Patients with tuberous
•sclerosis will not be excluded from study participation, unless there is a progressive
•2. Patient has had an episode of status epilepticus within 12 weeks of baseline.
•3. Patient has had an anoxic episode requiring resuscitation within 6 months of screening.
•4. Patient has a clinically significant history of an allergic reaction or significant sensitivity
•to benzodiazepines or to any of the other ingredients in clobazam tablets.
•5. Patient is taking more than 3 concurrent AEDs. NOTE: VNS or ketogenic diet is
•allowed and will not be counted in the three allowed AEDs.
•6. Patient has been on the ketogenic diet for less than 30 days prior to screening or suffers
•from frequent stooling.
•7. If the patient has a VNS, the settings have not been stable for at least 30 days prior to
•8. Patient has previously been treated with CLB.
•9. Patient has taken corticotropins in the 6 months prior to screening.
•10. Patient is currently taking long-term systemic steroids (excluding inhaled medication for
•asthma treatment) or any other daily medication known to exacerbate epilepsy. An
•exception will be made of prophylactic medication, for example, for idiopathic nephrotic
•syndrome or asthma.
•11. If the patient is taking felbamate, he/she has been taking it for less than 1 year prior to
•12. Patient has experienced a clinically significant unresolved idiosyncratic reaction to an
•AED, e.g., topiramate with resulting metabolic acidosis, felbamate with resulting
•aplastic anemia or hepatic failure, or lamotrigine with resulting skin irritation and/or
•13. Patient has shown any clinically significant history of hyper-sensitivity to central
•nervous system (CNS)-active medications leading to neurobehavioral aberrations (e.g.,
•increased biting, scratching, kicking or hitting).
•14. If the patient is on any chronic medication, the dose has not been stable for at least 30
•days prior to screening.
•15. Patient has taken or used any investigational drug or device in the 30 days prior to
•16. Patient has a clinically significant unstable hepatic, hematological, renal, cardiovascular,
•gastrointestinal, or pulmonary disease or ongoing malignancy.
•17. Patient has a diagnosis of sleep apnea.
•18. Patient has compromised respiratory function or severe respiratory insufficiency.
•19. Patient has a clinically significant abnormal laboratory value.
•20. Patient has familial long QT syndrome, QT/QTc >500msec or a history of polymorphic
•ventricular tachycardia.
•21. Patient has a progressive CNS lesion confirmed by magnetic resonance imaging (MRI)
•or computed tomography (CT) scan.
•22. Patient has a history of drug or alcohol abuse.
•23. Patient has a history of poor compliance on past antiepileptic therapy.
•24. Patient has inadequate supervision by parent or guardian.
•25. For any reason, the patient is considered by the investigator to be an unsuitable
•candidate for the study.
•26. Patient has a history of severe muscle weakness, including myasthenia gravis.

研究者

发起方

undbeck Inc

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